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Table 1 Patients demographics and baseline characteristics (ITT population)

From: Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial

  Placebo (n = 93) Duloxetine (n = 91)
Age, (years) 15.33 (1.42) 15.74 (1.38)
Gender, n (%)
 Female 65 (69.89) 73 (80.22)
Race, n (%)
 Caucasian 70 (75.27) 72 (79.12)
 African American 8 (8.60) 7 (7.69)
 Asian 7 (7.53) 6 (6.59)
 American Indian or Alaska 0 1 (1.10)
 Native Hawaiian or Others 1 (1.08) 0
 Multiracial 6 (6.45) 4 (4.40)
BMI, kg/m2 24.10 (5.92) 24.11 (7.09)
Country, n (%)
 Argentina 19 (20.43) 19 (20.88)
 India 7 (7.53) 6 (6.59)
 Puerto Rico 3 (3.23) 2 (2.20)
 United States 64 (68.82) 64 (70.33)
Time since diagnosis for fibromyalgia, years mean (SD) 0.38 (1.24) 0.19 (0.47)
BPI Average Pain, (0–10)
 Average Pain Score 5.63 (1.531) 5.68 (1.365)
 worst pain score 6.87 (1.889) 7.11 (1.835)
 least pain score 3.84 (1.974) 3.67 (2.108)
 Pain score right now 5.19 (2.295) 5.18 (2.488)
BPI interference
 General activity 5.11 (2.343) 5.23 (2.362)
 Mood 5.08 (2.638) 4.89 (2.639)
 Walking ability 4.55 (2.819) 4.16 (2.857)
 Normal work 4.90 (2.533) 4.65 (2.614)
 Relations with other people 3.73 (2.840) 3.71 (2.778)
 Sleep 5.60 (3.047) 5.89 (2.877)
 Enjoyment of life 4.29 (2.831) 4.04 (3.080)
 School work 4.26 (3.240) 4.86 (3.046)
BPI average interference Score (0–10) 4.69 (2.186) 4.68 (2.194)
PPQ score (0–100)
 Average pain score 57.51 (21.867) 61.45 (19.832)
 Worst pain score 74.43 (21.295) 77.57 (20.005)
 Pain score right now 51.16 (25.831) 49.91 (27.285)
CGI-S Score (1–7)
 Overall 4.1 (0.8) 4.1 (0.9)
 Mental illness 2.03 (1.146) 2.11 (1.224)
FDI total score (0–60)
 Child total score 21.93 (10.046) 23.45 (11.129)
 Parent total score (0–60) 22.12 (10.710) 22.87 (11.485)
CDI total score (0–54) 12.97 (7.645) 13.56 (7.078)
MASC total score (0–117) 43.61 (18.797) 45.56 (16.818)
Current medical status, Yes, n (%)
 Major depressive disorder 15 (16.13) 17 (18.68)
 Generalized anxiety disorder 6 (6.45) 10 (10.99)
 Attention deficit disorder 7 (7.53) 4 (4.40)
Concurrent/ongoing Therapy for FM Symptoms
 Psychotherapy 7 (7.5) 12 (13.2)
 Physical Therapy 4 (4.3) 7 (7.7)
  1. Values are mean (SD), unless specified; BMI body mass index, BPI Brief Pain Inventory, CDI Children’s Depression Inventory, CGI-S Clinical Global Impression: Severity, FDI Functional Disability Inventory, MASC Multidimensional Anxiety for Children, PPQ Pediatric Pain Questionnaire, SD standard deviation, n number of patients. BPI, 0 (no pain) to 10 (pain as bad as one can imagine); PPQ, 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain); CGI-S, 1 (normal, not at all ill) to 7 (among the most extremely ill patients); FDI, higher the score, more physical trouble or difficulty the child has doing regular activities; CDI, higher the score, more severe the depression; MASC, higher the total score, more severe the anxiety